Lawsuit Updates: The Latest on Lipitor & Crestor

A mounting number of Lipitor diabetes lawsuits have been filed against Pfizer, the maker of the medication. Lipitor, also known generically as atorvastatin, is a member of the statin class of medications used to reduce blood levels of low-density lipoprotein (LDL) cholesterol, or “bad” cholesterol, a contributing factor in heart disease.

• In 2012, Pfizer updated the Lipitor labeling to include warnings of increased risk for diabetes; however, the lawsuits contend that this was insufficient.

• The Lipitor lawsuits allege Pfizer has failed to adequately warn consumers of the risk for developing diabetes associated with the statin.

Here we provide an update on Lipitor litigation

• In June, 2013, a motion to consolidate Lipitor lawsuits into a multidistrict litigation (MDL) was put forward. The motion filed by the plaintiffs involved centralizing three actions pending in the District of South Carolina, one action in the Southern District of Illinois and one action in the Eastern District of Virginia.

• In September 2013, a federal panel of judges subsequently denied the motion for a Lipitor diabetes MDL. In making their decision, the judges noted that there was a small number of Lipitor diabetes lawsuits filed, and that many were already pending in a single district.

• The judges noted in their order that there were factors in the lawsuits that favored consolidation of the claims, including that the lawsuits made similar allegations.

• However, the judges wrote, almost half of the lawsuits already filed are pending in the District of South Carolina. Furthermore, the lawsuits are already moving before one judge in a coordinated manner. Finally, Pfizer reportedly told the judges that it would work with the plaintiffs’ lawyers in non-South Carolina actions, to coordinate common discovery.

• According to the judges, the plaintiffs have suggested that many more Lipitor lawsuits are likely to be filed (the judges noted that they were aware of 23 more federal actions in addition to those they were considering); the judges were not willing to consolidate lawsuits based on the potential of future lawsuits.

• Based on those factors, the judges determined that a transfer and consolidation order regarding Lipitor was not necessary and denied the motion. The motion was issued in regards to MDL No. 2459, In Re: Lipitor (Atorvastatin Calcium) Marketing, Sales Practices and Products Liability Litigation, United States Judicial Panel on Multidistrict Litigation.

• An MDL is more practical for both the plaintiffs and the judicial system, as it allows for trying all cases on an individual basis. An MDL is a special federal legal procedure that speeds up the process of handling complex cases such as complex product liability lawsuits. An MDL can take place when civil actions involving one or more common questions of fact are pending in different districts. Additionally, MDLs reduce the likelihood of duplicative discovery and conflicting pretrial rulings from different judges.

Crestor litigation update

According to the US Food and Drug Administration (FDA), Crestor, known generically as rosuvastatin, is associated with a low incidence of rhabdomyolysis (severe muscle damage) and various forms of kidney failure.

• Crestor belongs to the statin class of medications and was approved in the US in August 2003.

• In 2005, Astra-Zeneca Pharmaceuticals, the maker of Crestor, changed the drug’s label to reflect the risk of serious muscle toxicity (myopathy/rhabdomyolysis). Although premarketing trials indicated a risk of muscle damage - a side effect seen in other statins - the updated label reflected data from studies indicating that Asian people could be at an increased risk of muscle damage. The new label recommended that Asian patients be started on the 5 mg dose.

• In October 2012, the FDA announced a change to Crestor’s warning label, alerting patients to the risk of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy that is associated with statin use. Symptoms of IMNM include proximal muscle weakness and increased serum creatine kinase, both of which can continue after treatment with Crestor has stopped. The FDA notes that this side effect is rare.